Systems and methods for anchoring medical devices

ABSTRACT

Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors.

CLAIM OF PRIORITY

This application is a divisional application which claims priority toU.S. patent application Ser. No. 13/713,239, filed on Dec. 13, 2012, theentire contents of which are hereby incorporated by reference.

TECHNICAL FIELD

This document relates to devices, systems, and methods for securing theposition of a catheter or another medical instrument, for example, at askin opening.

BACKGROUND

Venous, arterial, and body fluid catheters are commonly used byphysicians. For example, such catheters may be used to gain access tothe vascular system for dialysis, for introducing pharmaceutical agents,for nutrition or fluids, for hemodynamic monitoring, and for blooddraws. Alternatively, catheters can be used for drainage of fluidcollections and to treat infection. Alternatively, catheters can containelectrical leads for neuro-stimulation, cardiac pacing, and the like.Following introduction into the patient, the catheter is secured to thepatient. In many instances, the catheter is commonly secured to thepatient using an adhesive tape on the skin or by suturing a catheter hubto the patient's skin. In other circumstances, the catheter may besecured to the patient using a subcutaneous anchor mechanism (such as ananchor sleeve equipped with anchors that are deployed using an externalactuator handle or a separate delivery device). In many cases, themedical practitioner will make efforts to clean the skin area around thecatheter insertion site for purposes of a patient's comfort, safety, andimproved visualization of the catheter insertion site after the catheteris installed.

SUMMARY

Some embodiments of a medical device anchor system include an anchordevice that provides an adhesive coupling with a medical instrument(such as a catheter or the like that is optionally equipped with suturewings) and furthermore secures the instrument in place relative to askin penetration point. For example, the medical anchor device can beequipped with a flexible fabric portion that is configured to adhesivelyattach to a shaft of a hub of a catheter while the medical anchor devicealso provides subcutaneous anchor mechanisms deployable through the skinpenetration point that is already occupied by the catheter, therebyreducing or eliminating the need for installing sutures through thesuture wings and the patient's skin. Optionally, in some embodiments theanchor device can be adjusted to a folded configuration that orients thetines of the subcutaneous anchors in a generally side-by-sideconfiguration to facilitate insertion of the anchors through the skinpenetration point. Such a configuration may allow the anchor device tobe installed after medical instrument is already in place without theneed for a second penetration point for the anchor device. In particularembodiments, the anchor device may be configured to simplify the use ofthe anchor device, make the anchor device more adaptable to use withmedical instruments of different sizes, and to facilitate themaintenance and cleaning of the skin tissue at and around the skinpenetration point.

In particular embodiments, an anchor device for securing the position ofa medical instrument may include a retainer body. The retainer body caninclude a first body portion that is hingedly coupled to a second bodyportion about a longitudinal folding region. Also, the anchor device mayinclude one or more flexible adhesive strips mounted to the retainerbody. The one or more flexible adhesive strips can be configured toadhesively attach with one or more corresponding exterior surfaces of amedical instrument. The anchor device may further include first andsecond anchors that extend distally from a distal end of the retainerbody. Each anchor may include a flexible tine that is deployable in asubcutaneous region to secure the retainer body relative to apenetration point. The first anchor may be coupled to the first bodyportion, and the second anchor may be coupled to the second bodyportion. The first body portion of the retainer body can be hingedlymovable relative to the second body portion about the longitudinalfolding region so that the first and second anchors are adjustable froma first configuration in which the flexible tines extend outwardly awayfrom one another to a second configuration in which the flexible tinesextend generally in the same direction.

Some embodiments of an anchor device may include a retainer body andfirst and second flexible adhesive strips. The retainer body may includea first body portion that is pivotably coupled to a second body portionabout a longitudinal fold axis. The first and second flexible adhesivestrips may be configured to mate with an external structure of a medicalinstrument to adhesively couple the medical instrument to the retainerbody. The first flexible adhesive strip may be mounted to the first bodyportion of the retainer body, and the second flexible adhesive strip maybe mounted to the second body portion of the retainer body. The anchordevice can also include first and second anchors that extend distallyfrom a distal end of the retainer body. Each anchor may include aflexible tine that is deployable in a subcutaneous region to secure theretainer body relative to a penetration point. The first anchor may becoupled to the first body portion, and the second anchor may be coupledto the second body portion. The first body portion of the retainer bodymay be pivotable relative to the second body portion about thelongitudinal fold axis so that the first and second anchors areadjustable from a first configuration in which the flexible tines extendoutwardly away from one another to a second configuration in which theflexible tines extend generally in the same direction.

Other embodiments described herein include a system for securing theposition of a medical instrument. The system may include a medicalinstrument comprising a distal portion configured to extend through askin penetration point and into a body, and an external portionconfigured to reside outside the body when the distal portion extendsthrough the skin penetration point. The system may also include ananchor device. The anchor device may comprise a retainer body includinga first body portion that is pivotably coupled to a second body portion.The anchor device may also comprise one or more flexible adhesive stripsmounted to the retainer body. The one or more flexible adhesive stripsmay be configured to adhesively attach with one or more surfaces of theexternal portion of the medical instrument. The anchor device mayfurther comprise first and second anchors that extend distally from adistal end of the retainer body. Each anchor may include a flexible tinethat is deployable through the skin penetration point occupied by themedical instrument and into a subcutaneous region to secure the retainerbody relative to the skin penetration point. The first anchor may becoupled to the first body portion, and the second anchor may be coupledto the second body portion. The first body portion of the retainer bodymay be pivotable relative to the second body portion so that the firstand second anchors are adjustable from one another to a removalconfiguration in which the flexible tines extend generally in the samedirection.

Some embodiments described herein include a method of using a medicalanchor system. The method may include advancing an anchor device towarda skin penetration point while the anchor device is in a foldedcondition so that a plurality of subcutaneous tines of the anchor deviceare generally adjacent to each other and oriented to extend insubstantially the same direction. The method may also include insertingthe subcutaneous tines through the skin penetration point and into asubcutaneous region adjacent to an underside of a skin layer while theanchor device is in the folded condition. Each of the subcutaneous tinesmay have a shape which terminates at a tip of a free end duringinsertion through the skin penetration point. The method may furtherinclude adjusting the anchor device to a non-folded condition after thesubcutaneous tines are inserted into the subcutaneous layer so that thesubcutaneous tines are in an anchored position in which the free ends ofthe subcutaneous tines extend generally away from one another. Also, themethod may include adhesively securing a medical instrument to theanchor device after the subcutaneous tines are adjusted to the anchoredposition in the subcutaneous region. The operation of adhesivelysecuring may include coupling one or more flexible adhesive members ofthe anchor device with one or more exterior surfaces of the medicalinstrument.

These and other embodiments may provide one or more of the followingadvantages. First, some embodiments of an anchor system can retain amedical instrument in a desired position relative to a skin penetrationpoint without necessarily requiring sutures or skin adhesives. Second,particular embodiments of the anchor device may be readily adaptable touse with catheters or other medical instruments of different sizes,while also securing the catheter or medical instrument to a skinpenetration point in a manner that facilitates improved inspection andcleaning of the skin tissue at and around the skin penetration point.For example, some of these particular embodiments of the anchor devicecan provide a capless design in which an adhesive fabric of the anchordevice adhesively couples the anchor device to an external portion ofthe catheter or medical instrument without the need for an attachablecap device, thereby simplifying the process for a practitioner to couplethe anchor device to the catheter or medical instrument. As anotherexample, some of these particular embodiments include a tear strip inthe adhesive fabric to permit a practitioner to decouple the catheter ormedical device from the anchor device. Third, in some embodiments, theanchor device may be adjusted between a folded configuration and anon-folded configuration so that the subcutaneous anchors are arrangedside-by-side and extend in generally the same direction during bothinstallation through and removal from the skin penetration point.Fourth, in some embodiments, the anchor device can be installed inaccordance with a technique that reduces or eliminates the need to shiftthe subcutaneous tines to or from a flexed or stressed configuration.Thus, in these embodiments, the subcutaneous anchors may be readilyinstalled and removed from the skin penetration point without the needfor a separate external actuator or delivery device. Fifth, in someembodiments, the configuration of the anchor device can simplify theprocess of installing a medical instrument onto the anchor device andremoving the medical instrument from the anchor device. Sixth, in someembodiments, the anchor device can be configured to be usable with avariety of styles and sizes of medical instruments. Seventh, in someembodiments, the anchor device can enable a hub of a catheter or othermedical instrument to be positioned in close proximity to the skinpenetration point.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an anchor device with a portion of thedevice located in a subcutaneous region, in accordance with someembodiments.

FIGS. 2A-2C are perspective, side, and rear views, respectively, of theanchor device of FIG. 1.

FIGS. 3A-3B are perspective and top views, respectively, of the anchordevice of FIG. 1 in a folded condition, in accordance with someembodiments.

FIGS. 4-7A are perspective views of an anchor system, including theanchor device of FIG. 1, for use in securing the position of a medicalinstrument.

FIG. 7B is a rear view of the anchor system, including the anchor deviceof FIG. 1.

FIG. 8 is a perspective view of the anchor system, including the anchordevice of FIG. 1.

FIG. 9 is a perspective view of an anchor device with a portion of thedevice located in a subcutaneous region, in accordance with someembodiments.

FIGS. 10A-C are perspective, side, and rear views, respectively, of theanchor device of FIG. 9.

FIGS. 11A-B are perspective and top views, respectively, of the anchordevice of FIG. 9 in a folded condition, in accordance with someembodiments.

FIGS. 12-16 are perspective views of an anchor system, including theanchor device of FIG. 9, for use in securing the position of a medicalinstrument.

FIGS. 17A-17B are perspective and side views, respectively, of an anchordevice in accordance with some alternative embodiments.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIG. 1, some embodiments of a medical device anchor system104 include an anchor device 100 that adhesively attaches to a medicalinstrument 102 and furthermore secures the medical instrument 102 in anoperative position relative to a portion of skin 30. The medicalinstrument 102 can be adhesively coupled to the anchor device 100 afterthe medical instrument 102 using, for example, a flexible fabric portion170 having an adhesive layer thereon. The anchor device 100, in turn,can be coupled to the portion of skin 30 using one or more subcutaneousmembers 145 a-b. In this manner, the anchor device 100 can act as anintermediary member to cause the retention of the medical instrument 102in a desired position with respect to the skin 30. The exampleembodiment of FIG. 1 can include the medial instrument 102 (e.g., acentral venous catheter 102) inserted through a percutaneous openingformed in the skin (e.g., penetration point 32), proceeding to theunderside of the skin 30, and into a vein 40 to provide vascular accessfor delivering medications, withdrawing fluids, or providing minimallyinvasive access into a patient.

In this example, the anchor device 100 can generally include a retainerbody 110, adhesive fabric 170, and one or more anchors 140 a-b. Theadhesive fabric 170 extends proximally from a proximal end of theretainer body 110. The one or more anchors 140 a-b extend distally froma distal end of the retainer body 110. As described further below, theanchor device 100 can be configured to couple with the medicalinstrument 102. The one or more anchors 140 a-b can be configured fordeployment through a skin penetration point 32 and into a subcutaneouslayer 34, so as to releasably retain the anchor device 100 with respectto the skin 30. For example, the anchor device 100 can include the oneor more anchors 140 a and 140 b that extend distally from the retainerbody 110 so as to penetrate through the same skin penetration pointwhile the retainer body 110 (and the adhesive fabric 170 mountedthereto) remain external to the skin penetration point 32. In someembodiments, the skin penetration point 32 may be defined by a smallincision, a puncture, or the like through the dermal layers 36.

The anchors 140 a-b can include subcutaneous tines 145 a-b that, afterinsertion, reside in the subcutaneous region 34 (e.g., a regionimmediately under the skin 30 that may comprise a fatty tissue layer) soas to secure the position of the anchor device—and the medicalinstrument 102 retained therein—relative to the penetration point 32.When the tines 145 a-b are deployed in the subcutaneous region 34, theanchor device 100 can be secured to the patient without the retainerbody 110 penetrating through the dermal layers 36 of the patient, andwithout necessarily requiring sutures or adhesive tapes bonded to theskin 30.

As described in more detail below in connection with FIGS. 4-8, theanchor device 100 can be installed into a skin penetration point 32 inaccordance with a technique that reduces or eliminates the need to shiftthe subcutaneous tines 145 a-b of the anchors 140 a-b to or from aflexed or stressed configuration. As such, the anchor tines 145 a-b neednot undergo substantial flexing during installation or removal. In thesecircumstances, the subcutaneous anchors may be both installed andremoved from the skin penetration point 32 advantageously without theneed for an external actuator handle or delivery device to deploy thesubcutaneous tines 145 a-b. It should be understood that, in alternativeembodiments, the anchor tines 145 a-b may be flexed to a different shapeduring installation or removal.

Still referring to FIG. 1, after installation of the subcutaneous anchortines 145 a-b into the subcutaneous layer 34, the retainer body 110 andthe adhesive fabric 170 can receive the medical instrument 102. In thisembodiment, the adhesive fabric 170 receives the medical instrument 102after a release liner 174 is removed from the adhesive fabric 170 toexpose an adhesive layer 172 (FIGS. 2A-C). The release liner 174 may beremoved before installation of the subcutaneous tines 145 a-b throughthe skin opening 32 or after installation of the subcutaneous tines 145a-b through the skin opening 32. The medical instrument 102 may beplaced in contact with the exposed adhesive fabric 170, and a user mayfold the adhesive fabric 170 over the medical instrument 102 to securethe medical instrument 102 to the anchor device 100.

Accordingly, in some embodiments, the anchor device 100 can provide acapless design in which the anchor device 100 adhesively couples with anexternal portion of the medical instrument 102 without the need forattaching a cap or other similar component onto the retainer body 110,thereby simplifying the process of inspecting and cleaning the anchordevice 100 and the skin surface near the skin penetration point 32 afterinstallation. It should be understood that, in alternative embodiments,the retainer body 110 can be configured so as to mate with a capcomponent so as to supplement the holding force upon the medicalinstrument beyond the holding force provided from the adhesive fabric170.

In the depicted example, the medical instrument 102 is embodied as acatheter. Hence, hereinafter the medical instrument 102 mayalternatively be referred to as catheter 102, without limiting themedical instrument 102 to such an embodiment. In this embodiment, theexample catheter 102 generally includes a proximal portion 26, a centralportion 22, and a distal portion 28. The central portion 22 caninterconnect the proximal portion 26 with the distal portion 28. In someembodiments, the proximal portion 26 of the catheter 102 may havemultiple lumens (not shown) that are suited to deliver multiple types ofsolutions to the patient. In some embodiments, the catheter 102 includesa hub (e.g., hub 42 as described with respect to FIGS. 9-16) that canreceive the multiple lumens on the proximal end of the hub, and mergethe multiple lumens so as to connect with a single shaft of the distalportion 28.

Referring now to FIGS. 2A-2B, some embodiments of the anchor device 100include the retainer body 110 and the anchors 140 a-b, which areconnected to and extend distally from the distal end of the retainerbody 110. For example, the anchors 140 a and 140 b can be connected tothe retainer body 110 using an over-molding process to secure theanchors 140 a-b relative to the retainer body 110. It should also beunderstood that there exist many manufacturing processes that can securethe anchors 140 a and 140 b to the retainer body 110. In someembodiments, the retainer body 110 and the anchors 140 a and 140 b canbe manufactured as a single, unitary piece.

In particular embodiments, the anchor device 100 can be configured to befolded longitudinally about a longitudinal fold axis 160 (e.g., alongitudinally extending region configured for enabling the retainerbody 110 to repeatedly adjust from a first position to a second, foldedposition as shown, for example, in FIGS. 3A-3B). Consequently, theretainer body 110 can be described as having a first retainer bodyportion 120 a and a second retainer body portion 120 b. In someembodiments, the first and second retainer body portions 120 a-b can besubstantially mirror images of each other. In alternative embodiments,the first and second portions of the anchor device 100 can beasymmetrical.

Preferably, at least a portion of each anchor 140 a-b comprises aflexible material. In some embodiments, the anchors 140 a-b may comprisea material that exhibits superelasticity. In some embodiments, at leasta portion of the anchors 140 a-b (including the tines 145 a-b) may beformed from a length of nitinol wire or from a sheet of nitinolmaterial. Alternatively, the anchors 140 a-b may comprise a metalmaterial such as stainless steel (e.g., 304 stainless, 316 stainless,custom 465 stainless, and the like), spring steel, titanium, MP35N, andother cobalt alloys, or the like. In another alternative, the anchors140 a-b may be formed from a resilient polymer material. In someembodiments, the anchors 140 a-b can be formed from a material ormaterials that allow the tines 145 a-b to be flexed and resilientlyreturn to an unstressed position.

In the embodiment depicted in FIGS. 2A-C, each of the anchors 140 a-bmay be designed such that the tines 145 a-b have an unstressed positionwherein the tines 145 a-b have a convex curvature. The convex curvatureshape of the tines 145 a-b may permit the tines 145 a-b to abut againstthe underside of the dermal layers 36 in a manner that reduces thelikelihood of the tine tips 146 puncturing the underside of the dermallayers 36. Preferably, the tine tips 146 are rounded bulbs or otherwisenon-sharp so as to further protect the underside of the dermal layers36. In alternative embodiments, the tines 145 a-b may have a generallystraight shape that extends substantially perpendicular to thelongitudinal shaft portions of the anchors 140 a-b to the rounds tips146.

The retainer body 110 can comprise one or more biocompatible polymermaterials (e.g., PVC, polypropylene, polystyrene, or the like). In someembodiments, the retainer body 110 can comprise a combination of suchmaterials, for example, when the flexible web portion comprises anelastically flexible silicone material while the first and secondretainer body portions 120 a-b comprise a less flexible polymer materialsuch as polypropylene, PVC, polystyrene, or the like. In someembodiments, the retainer body 110 can be formed using a molding processin which the retainer body 110 is over-molded around a portion of theanchors 140 a-b, especially in those embodiments in which the anchors140 a-b comprise a metallic material. For example, the left retainerbody portion 120 a can be over-molded around a portion of anchor 140 aand, during the same or a different molding process, the right bodyportion 120 b can be over-molded around a portion of anchor 140 b.Consequently, as described further below, when the retainer body 110 isfolded, the respective anchors 140 a-b (being connected to the retainerbody portions 120 a-b respectively) likewise move in conjunction withtheir respective retainer body portion 120 a-b.

Still referring to FIGS. 2A-C, the adhesive fabric 170 of the anchordevice is optionally mounted to the retainer body 110 so that theadhesive fabric 170 extends proximally away from a proximal end of theretainer body 110 (e.g., extends away from the anchors 140 a-b). Theadhesive fabric 170 may include a flexible substrate 175 on which anadhesive layer 172 has been formed (see FIG. 2B). For example, theflexible substrate 175 may comprise a mesh material or flexible wovenmaterial. The anchor device 100 may be manufactured with a releasableliner 174 covering the adhesive layer 172 to preserve the adhesivecharacteristics and to limit exposure of the adhesive layer 172 toenvironmental contaminants prior to user removal of the releasable liner174. In practice, a user may readily remove the releasable liner 174from the adhesive fabric 170 after installation of the subcutaneousanchor tines 145 a-b into the subcutaneous layer 34. The user maythereafter place the catheter 102 in contact with the adhesive layer172, and fold a portion of the adhesive fabric 170 over top of thecatheter 102 and onto another portion of the adhesive fabric. In thisway, the catheter 102 may be sandwiched between two portions of theadhesive fabric 170, securing the catheter 102 to the anchor device 100.Thus, although the adhesive layer 172 is employed to secure the catheter102 to the anchor device 100, the catheter 102 is anchored to the skin30 using the subcutaneous tine 145 a-b (without the need to apply anadhesive directly to the skin 30).

In some embodiments, the adhesive fabric 170 may include a tear strip180 that extends in a generally longitudinal direction (e.g., generallyparallel to the longitudinal fold axis 160 of the retainer body 110).The adhesive fabric may be adapted such that pulling the tear strip 180results in the adhesive fabric 170 separating along an installation ofthe tear strip 180 in the adhesive fabric 170. Said another way, thetear strip 180 may be adapted to separate the adhesive fabric 170 intomultiple portions as a result of a user pulling the tear strip 180 awayfrom the adhesive fabric 170, for example, in a direction that isgenerally traverse to a plane of the adhesive fabric 170. The tear strip180 may embody a continuous polymer thread that is located within one ormore layers of the flexible substrate 175. Optionally, the flexiblesubstrate 175 may be perforated along the location of the tear strip 180to facilitate separation of the adhesive fabric 170 as a result of theuser pulling the tear strip 180 away from the adhesive fabric 170. Thetear strip 180 may be manufactured with sufficient tensile strength toremain intact as the user pulls the tear strip 180 away from theadhesive fabric 170, and as the adhesive fabric 170 is ripped into twoportions through force applied to the adhesive fabric 170 by the tearstrip 180.

In some embodiments, the tear strip 180 may include a protruding portion182 that is adapted to be grasped by the user with an instrument orbetween the user's fingers. The protruding portion 182 may be amost-proximal portion of the anchor device 100. The tear strip 180 maybe positioned in the adhesive fabric 170 such that the tear strip 180 islocated generally longitudinally along the catheter 102 when theadhesive fabric 170 is folded over the catheter 102. In this manner,after the catheter 102 has been secured to the anchor device 100, thepractitioner is able to remove the catheter 102 from the anchor device100 by pulling the tear strip 180 away from the adhesive fabric 170,separating the adhesive fabric 170 along a length of the catheter 102and permitting removal of the catheter 102 through the separation in theadhesive fabric 170 while the adhesive fabric remains adhesively bondedto itself. The user may not grasp, for example, a corner of the adhesivefabric 170 and peel the corner of the adhesive fabric 170 off anotherportion of the adhesive fabric 170. Thus, after adhesive coupling of thecatheter 102 to the anchor device 100, the catheter 102 may be removedin a straightforward manner from contact with the anchor device 100 andsubcutaneous region 34 before the tines 145 a-b are removed from thesubcutaneous region 34. Said another way, the anchor device 100 may beremoved from the subcutaneous region 34 after catheter 102 has beenremoved from contact with the anchor device 100 and the subcutaneousregion 34. The adhesive fabric 170 may remain folded over and adhesivelybonded to itself (although separated into multiple portions) duringremoval of the anchor device 100 from the subcutaneous region 34.

The flexible substrate 175 of the adhesive fabric 170 can bemanufactured from a flexible material such as a textile mesh, a polymermesh, a polymer sheet, a flat web of polymer foam material, or ametallic foil. The adhesive layer 172 may comprise an adhesive, forexample, a suitable medical adhesive. In some examples, a medicaladhesive that is robust to cleaning agents and that provides a permanenthold may be employed as the adhesive layer 172. The releasable liner 174may be formed of a polymer sheet or a wax paper, for example.

Still referring to FIGS. 2A-C, the adhesive fabric 170 can be configuredto provide an effective coupling interface with the catheter 102 orother medical instrument, while providing features that simplify theoverall use of the medical device anchor system 10. For example, in thisembodiment, the adhesive fabric 170 may provide the user with asimplified coupling technique for mating the anchor device 100 to thecatheter 102, and may furthermore do so without the need for anattachable cap device. In the depicted example, the adhesive fabric 170in general is mounted to the retainer body 110, for example, so that theadhesive fabric may be folded along a fold axis 184 of the adhesivefabric 170 (e.g., a longitudinally extending region configured for theadhesive fabric 170 to fold upon itself). The fold axis 184 of theadhesive fabric 170 may be offset from but parallel to the longitudinalfold axis 160. The tear strip 180 may be located such that the tearstrip 180 is substantially with the longitudinal fold axis 160 when theadhesive fabric 170 has been folded along the fold axis 184 (refer toFIG. 1). The tear strip 180 and the fold axis 184 of the adhesive fabric170 can define borders between different regions of the adhesive fabric170. Consequently, the adhesive fabric 170 can be described as having afirst adhesive fabric portion 170 a, a second adhesive fabric portion170 b, and third adhesive fabric portion 170 c.

The adhesive and flexible characteristics of the adhesive fabric 170enables a user to fold the first adhesive fabric portion 170 a and thesecond adhesive portion 170 b into adhesive contact with both thecatheter 102 and the third adhesive fabric portion 170 c. In thismanner, the first adhesive fabric portion 170 a and the second adhesivefabric portion 170 b each adhere to both the catheter 102 and the thirdadhesive fabric portion 170 c. Furthermore, the third adhesive fabricportion 170 c may adhere with the catheter 102. Thus, when securing themedical device 102 to the retainer body 110, the user can place thecatheter 102 in contact with the adhesive fabric 170, for example, alongthe longitudinal fold axis 160, and can thereafter fold the adhesivefabric 170 along the fold axis 184 (which may include a visual indiciaof the fold axis 184, such as a solid or dotted line imprinted on theadhesive fabric 170). During the folding, the user may align the tearstrip 180 with the catheter 102 and press the second adhesive fabricportion 170 b onto the catheter 102 and the third adhesive fabricportion 170 c, and can press the first adhesive fabric portion 170 aonto the catheter 102 and the third adhesive fabric portion 170 c. Thecontact of the catheter 102 with the first adhesive fabric portion 170a, the second adhesive fabric portion 170 b, and the third adhesivefabric portion 170 c may result in a snug coupling of the catheter 102to the anchor device 100.

In the embodiment shown in FIG. 2B, the adhesive fabric 170 is moldedinto a proximal portion of the retainer body 110 at junction 186, forexample, with an insert molding operation. In another example, junction186 may be a slot that is formed during a molding process, and theadhesive fabric 170 is bonded into the slot with a permanent adhesiveduring a manufacturing assembly process. In yet another example, theadhesive fabric 170 may be mechanically fastened into junction 186. Inan alternative example, the adhesive fabric 170 may include a tongueportion that is mechanically fastened or permanently adhered to anunderside of the retainer body 110 so that the adhesive fabric 170extends proximally away from the proximal end of the retainer body 110.

As will be described further below, the adhesive coupling of thecatheter 102 to the anchor device 100 generally restrains movement ofthe medical instrument 102 away from the skin penetration point 32.Further, the limited angular freedom of movement provided by the anchors140 a-b permits the shaft of the catheter 102 to closely align with theskin penetration point 32 and reduce the stresses applied by thecatheter 102 at the skin penetration point 32.

As shown in FIGS. 2A-B, some embodiments of the anchor device 100 alsoinclude a sloped nose region 130 along the retainer body 110. The slopednose region 130 can be a generally planar surface near the distal end ofthe retainer body 110 that is oriented at a different angle than thegenerally planar surfaces of the first and second retainer body portions120 a-b. The sloped nose region 130 can decline from the generallyplanar surfaces of the first and second retainer body portions 120 a-bsuch that the nose region 130 slopes downward in a distal directiontowards longitudinal shafts 142 a-b of the anchors 140 a-b (e.g., andthus downward to the skin penetration point 32 when the anchor tines 145a-b are deployed). The sloped nose region 130 can facilitate anorientation of the distal portion 28 of the medical instrument 102 thatis directed toward the skin penetration point 32. In this manner, thestresses that can potentially be exerted on the skin 30 proximal to theskin penetration point 32 by the distal portion 28 of the medicalinstrument 102 can be reduced.

As shown in FIG. 2C, a flexible web portion 150 of the retainer body 110can be positioned, for example, generally centrally between the firstand second retainer body portions 120 a-b. As previously described, theflexible web portion 150 can extend longitudinally from a distal face ofthe retainer body 110 to a proximal face of the retainer body 110, andcan be used to define the fold axis 160 about which the first and secondretainer body portions 120 a-b are pivotable from the non-foldedcondition (FIG. 2A) to the folded condition (FIG. 3A). The flexible webportion 150 can comprise an elastically flexible biocompatible polymermaterial (e.g., silicon, PVC, polypropylene, polystyrene, or the like).In some embodiments, the flexible web portion 150 can be made of thesame material as the other portions of the retainer body 110. In otherembodiments, the flexible web portion 150 can be made of a differentmaterial than the other portions of the retainer body 110. In such acase, the anchor device 100 can be made, for example, using a two-stepinsert molding operation. The flexible web portion 150 can be biased toresiliently maintain the non-folded shape of the anchor device 100 asdepicted in FIGS. 2A-2C. When the anchor device 100 is folded along thefold axis 160 due to a user's grasp (refer, for example, to FIG. 4), theflexible web portion 150 can undergo elastic deformation such thatflexible web portion 150 biases the anchor device 100 to return thenon-folded condition (FIGS. 2A and 5) upon release from the user. Inaddition or alternatively, the fabric 170 may also stretch along thelongitudinal axis 160 and bias the anchor device 100 to return to thenon-folded condition. In some embodiments, the fabric 170 may be twoseparate pieces of fabric that do not span the longitudinal fold axis160, such that the two separate pieces of fabric are not stretched at alocation of the longitudinal fold axis 160 when the anchor device is inthe folded condition.

Referring now to FIGS. 3A-3B, in this example embodiment, the anchordevice 100 may include features that allow the individual anchors 140a-b to be moved relative to each other so as to facilitate bothinsertion and removal of the anchor device 100 through the skinpenetration point 32. For example, the anchor device 100 may have afoldable configuration in which a first portion of the retainer body 110is pivotably coupled via a flexible hinge portion to a second portion ofthe retainer body 110.

More specifically, in this embodiment, the first retainer body portion120 a and the second retainer body portion 120 b can be flexibly pivotedwith respect to each other along a fold axis 160 extendinglongitudinally through the retainer body 110. To initiate the foldingprocess of the anchor device 100, the user can apply a bending momentabout the fold axis 160 to the first and second retainer body portions120 a-b. Such a bending moment can cause an elastic deformation of theflexible web portion 150 so as to fold the anchor device along the foldaxis 160 (refer to FIG. 3A). Because the adhesive fabric portion 170comprises the flexible substrate 175 and liner 174, the adhesive fabricportion 170 is sufficiently compliant to temporarily fold with theretainer body 110 during this operation. The first retainer body portion120 a can be fixedly coupled to the anchor 140 a, and the secondretainer body portion 120 b can be fixedly coupled to the anchor 140 b.Thus, as shown in FIG. 3A, when the first and second retainer bodyportions 120 a-b are pivoted about the fold axis 160, the two anchors140 a-b likewise pivot relative to one another. This process of pivotingcan cause the anchor device to transition from a non-folded condition(shown in FIGS. 2A-2C and in FIG. 1) in which the tines 145 a-b extendgenerally away from one another to a folded condition (shown in FIGS.3A-3B), in which the tines 145 a-b are generally adjacent to each otherand oriented to extend in substantially the same direction. Similarly,when the bending moment from the user is released, the anchor device canbe biased to return the anchor device 100 from the folded condition tothe non-folded condition. In the depicted embodiment, the tines 145 a-bcan be rotated about 75-degrees to about 105-degrees, and preferablyabout 90-degrees, during the transition between the non-folded conditionand the folded condition. As described in more detail below, the anchordevice 100 can be arranged in the folded condition during both insertionand removal of the subcutaneous tines 145 a-b so as to reduce thelikelihood of the tines 145 a-b causing damage to the skin 30.

Referring now to FIGS. 4-5, as previously described, the medicalinstrument 102 can optionally include a catheter to be inserted throughthe penetration point 32 of the skin 30 as part of a medical procedure.For example, in the embodiment depicted in FIG. 1, a central venouscatheter 102 can be inserted into a percutaneous opening surgicallyformed in the skin (e.g., penetration point 32), to the underside of theskin 30, and into a vein 40 to provide vascular access for deliveringmedications or minimally invasive devices into a patient.

After placement of the catheter 102 through the penetration point 32 ofthe skin 30, the user can grasp the anchor device 100 in the foldedcondition and approach the penetration point 32 such that the free endsof the tines 145 a-b are contemporaneously inserted through thepenetration point 32 while the tines 145 a-b are in a generallyside-by-side condition (as depicted in FIG. 4). In particularembodiments, the subcutaneous tines 145 a-b are inserted through theskin penetration point 32 while the user conveniently grasps theretainer body 110 of the anchor device 100 and applies an insertionforce until the convexly curved body portions of the subcutaneous tines145 a-b are positioned below the surface of the skin 30 (while theremainder of the anchor device 100 resides external to the skin 30).

As the anchor device 100 is inserted through the penetration point 32,the tines 145 a-b are maintained in a generally non-stressedconfiguration (e.g., a first shape or a steady-state shape) whilepassing through the penetration point 32 in a manner that reduces thelikelihood of trauma to the surrounding skin tissue 30. As the tines 145a-b are collectively advanced through the penetration point 32, the freeends of the tines 145 a-b are moved beneath the dermal skin layers 36 ofthe skin 30.

When the tines 145 a-b reach the subcutaneous region 34, the retainerbody 110 can adjusted to the unfolded condition so that the tines 145a-b are shifted relative to one another, resulting in the tines 145 a-bextending outwardly away from one another (as depicted in FIG. 5).During that process of unfolding the retainer body 110, each tine 145a-b may retain their generally non-stressed configuration (e.g., thefirst shape or the steady-state shape). Thus, the anchor device 100 canbe installed in accordance with a technique that reduces or eliminatesthe need to shift the subcutaneous tines 145 a-b to or from a flexed orstressed configuration during the passage through the skin penetrationpoint 32. Also, the adhesive fabric portion 170 of the anchor device 100is sufficiently compliant to temporarily fold and unfolded with theretainer body 110 during this process.

As previously described, the anchor device 100 can secure the catheter102 or other medical instrument relative to a skin penetration point 32.With the anchor device 100 positioned such that subcutaneous tines 145a-b are in their deployed configuration, as shown in FIG. 5, the usermay remove the releasable liner 174 of the adhesive fabric 170, exposingthe adhesive layer 174 of the adhesive fabric 170. (Alternatively, theuser may remove the releasable liner 174 before installation of thesubcutaneous tines 145 a-b into the subcutaneous region 34.) After thereleasable liner 174 has been removed, the previously inserted catheter102 can be placed in contact with the adhesive layer 174 of the adhesivefabric 170. As shown in FIG. 5, the directional arrow 198 depicts anexample motion of manually positioning the catheter 102 in contact withthe adhesive fabric 170 to prepare for the coupling of the catheter 102to the anchor device 100.

Referring now to FIGS. 6A-B, the catheter 102 can be placed in contactwith the anchor device 100 so that the shaft of the catheter 102, forexample, is generally aligned with the folding region 150 of theretainer body 110. In doing so, the catheter 102 is placed in contactwith the adhesive layer 172 of the third portion 170 c (FIG. 2A) of theadhesive fabric 170, thereby temporarily retaining the catheter 102 is aposition to receive the remaining portions 170 a-b of the adhesivefabric 170 over an upper side of the catheter 102. In order toadhesively couple the catheter 102 to the anchor device 102, the usermay fold the adhesive fabric 170 (with the adhesive layer 172 exposed)along the fold axis 184 (FIG. 2A) and onto the catheter 102, aligningthe tear strip 180 with the shaft of the catheter 102.

Referring now to FIGS. 7A-B, the anchor device of FIGS. 4-5 isadhesively coupled to the catheter 102. For example, the adhesive fabric170 has been folded along the fold axis 184 over the catheter 102. Thecatheter 102 may be firmly secured between the upper and lower portionsof adhesive fabric 170. In the embodiment shown in FIGS. 7A-B, the firstadhesive fabric portion 170 a is in adhesive contact with the thirdadhesive fabric portion 170 c while the second adhesive fabric portion170 b is in adhesive contact with the third adhesive fabric portion 170c. The first adhesive fabric portion 170 a, the second adhesive fabricportion 170 b, and the third adhesive fabric portion 170 c may allcontact the catheter 102. In this embodiment, the adhesive coupling ofthe catheter 102 to the anchor device 100 secures the catheter 102 tothe anchor device along at least two regions of the catheter 102 thatare on opposing sides of the catheter 102. With the adhesive fabric 170folded over itself and adhesively secured to itself and the catheter102, the catheter 102 is fixed to the anchor device 100.

FIG. 8 illustrates an example of removing of the catheter 102 (or othermedical instrument) from the anchor device 100. In this example, theuser can grasped the protruding portion 182 of the tear strip 180, andpull the protruding portion 182 away from the adhesive fabric 170,ripping the adhesive fabric 170 at the location of the tear strip 180and permitting removal of the medical device 102 through the separationin the adhesive fabric 170. FIG. 8 shows the system 104 during removalof the tear strip 180 and ripping of the adhesive fabric 170, but itshould be understood that the tear strip 180 may be completely removedfrom the adhesive fabric 170, resulting in a complete separation of theadhesive fabric 170, for example, along the previous location of thetear strip 180. It is after the complete separation of the adhesivefabric 170 that the catheter 102 may be removed from contact with theanchor device 100. In some examples, the catheter 102 is removed fromcontact with both the subcutaneous layer 34 and the anchor device beforethe subcutaneous tines 145 a-b are removed from the subcutaneous layer34.

In some embodiments, some components of the system 104 can be providedin a sterilized kit that pairs a particular type of catheter 102 orother medical instrument with a corresponding anchor device 100. Theparticular type of catheter 102 or other medical instrument in the kitis compatible for adhesively mating with the anchor device 100 the kit.Each kit can include one or more anchor devices 100 and the particulartype of catheter 102 or other medical instrument enclosed within aflexible packaging material, which preferably includes indicators thatidentify the type of catheter 102 or other medical instrument that isprovided along with instructions for deploying and removing the anchordevice 100. The kit may include a one-to-one ratio for the quantity ofanchor devices 100 to the quantity of catheters 102. In otherembodiments, the kit may include multiple anchor devices 100 (e.g.,having differently sized or shaped tines 145 a-b) for each catheter 102contained therein.

Alternatively, in some embodiments, the anchor device 100 can beprovided in individual, sterilized packets so that a user can readilyopen such a packet and access the selected anchor device prior toinsertion into the skin penetration point. Such individual packets caninclude a single anchor device enclosed within a flexible packagingmaterial, which preferably includes indicators that identify the typesof catheters or other medical instruments that are compatible foradhesively mating with the anchor device 100. As such, a user canreadily select one of the packets for use after the type of catheter ormedical instrument is selected for a particular patient.

FIGS. 9-16 show embodiments of a medical device anchor system 204 thatis similar in some respects to the medical device anchor system 104. Themedical device anchor system 204 includes an anchor device 200 thatincludes one or more adhesive fabric strips 270 a-b with multiple tearstrips 280 a-b.

Referring to FIG. 9, some embodiments of the medical device anchorsystem 204 include an anchor device 200 that adhesively retains amedical instrument 202 in an operative position relative to a portion ofskin 30. The medical instrument 202 can be adhesively coupled to theanchor device 200. The anchor device 200, in turn, can be coupled to theportion of skin 30. In this manner, the anchor device 200 can act as anintermediary member to cause the retention of the medical instrument 202in a desired position with respect to the skin 30. The exampleembodiment of FIG. 9, can include a medical device 202 (e.g., a centralvenous catheter) inserted through a percutaneous opening formed in theskin (e.g., penetration point 32), proceeding to the underside of theskin 30, and into a vein 40 to provide vascular access for deliveringmedications, withdrawing fluids, or providing minimally invasive accessinto a patient.

In this example, the anchor device 200 can generally include a retainerbody 210, adhesive fabric 270 a-b, and one or more anchors 240 a-b. Theanchors 240 a-b extend distally from a distal end of the retainer body210. As described further below, the anchor device 200 can be configuredto couple with the medical instrument 202. The one or more anchors 240a-b can be configured for deployment through a skin penetration point 32and into a subcutaneous layer 34, so as to releasably retain the anchordevice 200 with respect to the skin 30. For example, the anchor device200 can include the one or more anchors 240 a and 240 b that extenddistally from the retainer body 210 so as to penetrate through the sameskin penetration point 32 while the retainer body 210 and the adhesivefabric 270 a-b remain external to the skin penetration point 32.

The anchors 240 a-b can include subcutaneous tines 245 a-b that, afterinsertion, reside in the subcutaneous region 34 so as to secure theposition of the anchor device—and the medical instrument 202 retainedtherein—relative to the penetration point 32. When the tines 245 a-b aredeployed in the subcutaneous region 34, the anchor device 200 can besecured to the patient without the retainer body 210 penetrating throughthe dermal layers 36 of the patient, and without necessarily requiringsutures or adhesive tapes bonded to the skin 30.

As described in more detail below in connection with FIGS. 12-16, theanchor device 200 can be installed into the skin penetration point 32 inaccordance with a technique that reduces or eliminates the need to shiftthe subcutaneous anchors tines 245 a-b of the anchors 240 a-b to or froma flexed or stressed configuration. As such, the anchor tines 245 a-bneed not undergo substantial flexing during installation or removal. Inthese circumstances, the subcutaneous anchors may be both installed andremoved from the skin penetration point 32 advantageously without theneed for an external actuator handle or delivery device to deploy thesubcutaneous tines 245 a-b.

Still referring to FIG. 9, after installation of the subcutaneous anchortines 245 a-b into the subcutaneous layer 34, the retainer body 210 andthe adhesive fabric strips 270 a-b can receive the medical instrument202. For the adhesive fabric strips 270 a-b to receive the medicalinstrument 202, a user may have removed releasable liners 274 a-b fromthe adhesive fabric strips 270 a-b to expose adhesive layers 272 a-b.The releasable liners 274 a-b may have been removed before installationof the subcutaneous tines 245 a-b or after installation of thesubcutaneous tines 245 a-b. The medical instrument 202 may be placed incontact with the exposed adhesive fabric strips 270 a-b, and a user mayfold the adhesive fabric strips 270 a-b over the medical instrument 202.

In this example, the medical instrument 202 is embodied as a catheter.Hence, hereinafter the medical instrument 202 may alternatively bereferred to as catheter 202, without limiting the medical instrument 202to such an embodiment. Furthermore, in some embodiments, the anchordevice 200 can provide a capless design in which the anchor device 200adhesively couples with an external portion of the catheter 202 withoutthe need for attaching a cap onto the retainer body 210, therebysimplifying the process inspecting and cleaning the anchor device 200and the skin surface near the skin penetration point 32 afterinstallation.

In this embodiment, the example catheter 202 generally includes aproximal portion 46, a hub 42, and a distal portion 48. The hub 42 caninterconnect the proximal portion 46 with the distal portion 48. In someembodiments, the proximal portion 46 of the catheter 202 may havemultiple lumens that are suited to deliver multiple types of solutionsto the patient. In some such embodiments, the hub 42 can receive themultiple lumens on the proximal end of the hub 42, and merge themultiple lumens so as to connect with a single lumen distal portion 48.For example, as shown in FIG. 9, the proximal portion 46 is depicted ashaving two lumens, and the distal portion 48 as having a single lumenthat is adapted for percutaneous insertion through skin penetrationpoint 32. Hence, the hub 42 can serve the purpose of merging multipleproximal supply lumens into a single distal delivery lumen suited forinsertion into the patient.

The hub 42 can further be arranged to couple the catheter 202 onto theanchor device 200. In some embodiments, the hub 42 can include wings 24a-b. The wings 24 a-b can have features that facilitate the coupling ofthe hub 42 to the anchor device 200. For example, the wings 24 a-b maybe shaped to adhesively couple with the one or more adhesive fabricstrips 270 a-b. As another example, some embodiments of the hub 42 caninclude apertures 47 a-b in the wings 24 a-b (see FIG. 13). Theapertures 47 a-b can be located and sized to couple with correspondingfeatures of anchor devices that may not include the adhesive fabricstrips 270 a-b.

The hub 42 can be manufactured from an elastomeric or otherwise flexiblematerial, such as silicone or another biocompatible polymer material(e.g., PVC, polypropylene, polystyrene, or the like). In someembodiments, the hub 42 can be made from a combination of materials. Forexample, at least wings 24 a-b may comprise silicone or another flexiblebiocompatible material so that the wings 24 a-b and the apertures 47 a-bcan flexibly adjust to couple with the adhesive fabric strips 270 a-b orthe above-described retention posts, whereas the portions of the hub 42other than the wings 24 a-b may comprise a more rigid polymer material.

The anchor device 200 can be configured to adhesively couple to thecatheter 202 through use of the multiple adhesive fabric strips 270 a-b.A user may wrap the adhesive fabric strips 270 a-b around the wings 24a-b, respectively. The adhesive fabric strips 270 a-b may includebacking layers 275 a-b on which adhesive layers 272 a-b have been formed(see FIG. 10C). The anchor device 200 may be manufactured so thatreleasable liners 274 a-b cover the adhesive layers 272 a-b to limitexposure of the adhesive layers 272 a-b to environmental contaminantsand gases prior to user removal of the releasable liners 274 a-b. Inpractice, a user may remove the releasable liners 274 a-b from theadhesive fabric strips 270 a-b after installation of the subcutaneousanchor tines 245 a-b into the subcutaneous layer 34. The user maythereafter place the catheter 202 in contact with the retainer body 210,and fold portions of the adhesive fabric strips 270 a-b over top of thewings 24 a-b. In this way, the wings 24 a-b of the catheter 202 may beretained by at least portions of the adhesive fabric strips 270 a-b,securing the catheter 202 to the anchor device 200.

Each of the adhesive fabric strips 270 a-b may include a tear strip(e.g., tear strip 280 a or 280 b in the depicted embodiment). Asdiscussed with respect to the adhesive fabric 270 of FIGS. 1-8, each ofthe adhesive fabric strips 270 a-b may be adapted such that pulling therespective tear strip 280 a or 280 b results in the adhesive fabric 270a or 270 b separating along an installation of the tear strip 280 a or280 b in the adhesive fabric 270 a or 270 b. The tear strips 270 a-b,backing layers 275 a-b, and adhesive layers 272 a-b may be constructedof the same materials and function similarly to the tear strip 170,flexible substrate 175, and adhesive layer 272 that are described withreference to FIGS. 1-8. The tear strips 280 a-b may include protrudingportions 282 a-b that are adapted to be grasped by the user with aninstrument or between the user's fingers.

The tear strips 280 a-b may be positioned in the adhesive fabric strips270 a-b such that the tear strips 280 a-b generally run alongsidesurfaces 27 a-b when the adhesive fabric strips 270 a-b are folded overtop surfaces 29 a-b of the wings 24 a-b. In this manner, after thecatheter 202 has been secured to the anchor device 200, the user is ableto remove the catheter 202 from the anchor device 200 by pulling thetear strips 280 a-b away from the adhesive fabric strips 270 a-b,separating the adhesive fabric strips 270 a-b along the locations of theside surfaces 27 a-b and permitting removal of the catheter 202, forexample, without requiring the user to grasp corners of the adhesivefabric strips 270 a-b and peel the adhesive fabric strips 270 a-b offthe wings 24 a-b. Indeed, portions of the adhesive fabric strips 270 a-bmay remain adhesively bonded to the wings 24 a-b after removal of thecatheter 202. Thus, after adhesive coupling of the catheter 202 to theanchor device 200, the catheter 202 may be removed in a straightforwardmanner from contact with the retainer body 210 and the subcutaneousregion 34 before the tines 245 a-b are removed from the subcutaneousregion 34. Said another way, the anchor device 200 may be removed fromthe subcutaneous region 34 after catheter 202 has been removed fromcontact with the anchor device 200 and the subcutaneous region 34(except that the separated regions of the adhesive fabric strips 270 a-bmay remain in contact with the wings 24 a-b after pulling of the tearstrips 280 a-b).

Referring now to FIGS. 10A-B, some embodiments of the anchor device 200include the retainer body 210 and the anchors 240 a-b, which areconnected to and extend distally from the distal end of the retainerbody 210. For example, the anchors 240 a and 240 b can be connected tothe retainer body 210 using an over-molding process to secure theanchors 240 a-b relative to the retainer body 210. It should also beunderstood that there exist many manufacturing processes that can securethe anchors 240 a and 240 b to the retainer body 210. In someembodiments, the retainer body 210 and the anchors 240 a and 240 b canbe manufactured as a single, unitary piece.

In particular embodiments, the anchor device 200 can be configured to befolded longitudinally about a longitudinal fold axis 260 (e.g., alongitudinally extending region configured for enabling the retainerbody 210 to repeatedly adjust from a first position to a second, foldedposition as shown, for example, in FIGS. 11A-11B). Consequently, theretainer body 210 can be described as having a first retainer bodyportion 220 a and a second retainer body portion 220 b. In someembodiments, the first and second retainer body portions 220 a-b can besubstantially mirror images of each other. In alternative embodiments,the first and second portions of the anchor device 200 can beasymmetrical.

The composition and construction of the anchors 240 a-b may be the sameas that of anchors 140 a-b, discussed with reference to FIGS. 1-8. Forexample, the anchors 240 a-b may comprise a material that exhibitssuperelasticity. Moreover, each of the anchors 240 a-b may be designedsuch that the tines 245 a-b have an unstressed position wherein thetines 245 a-b have a convex curvature with tine tips 246 that are bulbs.The composition of the retainer body 210 and the connection of theretainer body 210 to the anchors 240 a-b may be the same as that of theretainer body 110 and the anchors 140 a-b.

Still referring to FIGS. 10A-C, the retainer body 210 can include firstand second retainer body portions 220 a-b arranged on opposing sides ofthe longitudinal fold axis 260, left and right tabs 222 a-b, and(optionally) a sloped nose region 230. The first and second retainerbody portions 220 a-b can be connected to each other at an elasticallyflexible web portion 150, which may be employed to define the fold axis260.

Still referring to FIGS. 10A-C, the adhesive fabric strips 270 a-b canbe configured to provide an effective coupling interface with thecatheter 202 or other medical instrument, while providing features thatsimplify the overall use of the medical device anchor system 204. Forexample, in this embodiment, the adhesive fabric strips 270 a-b mayprovide the user with a simplified coupling technique for mating theanchor device 200 to the catheter 202, and may furthermore do so withoutthe need for an attachable cap device or skin sutures. In the depictedexample, the adhesive fabric strips 270 a-b in general are sized andattached the retainer body 210, for example, so that the adhesive fabricstrips 270 a-b may be folded along fold axes 284 a-b of the adhesivefabric strips 270 a-b. The fold axes 284 a-b of the adhesive fabric 270may be offset from but parallel to the longitudinal fold axis 260. Thetear strips 280 may be located along the fold axes 284 a-b. The tearstrips 280 a-b of the adhesive fabric strips 270 a-b can define bordersbetween different regions of the adhesive fabric strips 270 a-b.Consequently, adhesive fabric 270 a can be described as having a firstadhesive fabric portion 270 c and a second adhesive fabric portion 270d, and the adhesive fabric 270 b can be described as having a firstadhesive fabric portion 270 e and a second adhesive fabric portion 270f. The fold axes 284 a-b may be defined along the tear strips 280 a-b.

The adhesive and flexible characteristics of the adhesive fabric strips270 a-b enable a user to fold the first adhesive fabric portions 270 cand 270 e onto the top surfaces 29 a-b of the wings 24 a-b. In thismanner, the first adhesive fabric portions 270 c and 270 e adhere to thetop surfaces 29 a-b of the wings 24 a-b of the catheter 210.Furthermore, second adhesive fabric portions 270 d and 270 f may adhereto bottom surfaces 31 a-b of the wings 24 a-b. Thus, when securing themedical device 202 to the retainer body 210, the user can place themedical device 202 in contact with at least one of the second adhesivefabric portions 270 d and 270 f, and can thereafter fold the adhesivefabric strips 270 a-b along the fold axes 284 a-b (which may include avisual indicia of the fold axes 284 a-b, such as solid or dotted linesimprinted on the adhesive fabric strips 270 a-b). During the folding,the user may press the first adhesive fabric portions 270 c and 270 eonto the top surfaces 29 a-b of the wings 24 a-b. The contact of thewings 24 a-b with the adhesive fabric strips 270 a-b may result in asnug coupling of the catheter 202 to the retainer body 210.

In the embodiment shown in FIG. 10B, the adhesive fabric strips 270 a-bare bonded to outer surfaces of the retainer body 210, for example witha medical adhesive. In other embodiments (not shown), the adhesivefabric strips 270 a-b are molded into the retainer body 210 atjunctions, for example, slots in the retainer body 210 with an insertmolding operation. The adhesive fabric strips 270 a-b may bemechanically latched into junction 270. It should also be understoodthat there exist many manufacturing processes that can secure theadhesive fabric strips 270 a-b to the retainer body 210.

As will be described further below in reference to FIG. 14, theflexibility of the wings 24 a-b can allow some limited angular freedomof movement between the hub 42 and the anchor device 200, whilegenerally restraining movement of the catheter 202 away from the skinpenetration point 32. Further, the limited angular freedom of movementpermits the hub 42 of the catheter 202 to be slightly titled relative tothe anchor device 200, thereby permitting the hub 202 and the distalportion 48 of the medical instrument to more closely align with the skinpenetration point 32 and reduce the stresses applied by the catheter 202at the skin penetration point 32.

Still referring to FIGS. 10A-C, the anchor device 200 further includesfirst and second tabs 222 a-b. The first and second tabs 222 a-b areconfigured to simplify the act of manipulating and folding the anchordevice 200. For example, as described further in reference to FIGS.11A-B, the user can adjust the first and second tabs 222 a-b in apivoting motion toward one another, which readily enables the user tofold the anchor device 200 along the longitudinal fold axis 260. Thefirst and second tabs 222 a-b are also configured to provide a u-shapedcutout region 265 between the first and second tabs 222 a-b. Thisu-shaped cutout region 265 can more readily provide visualization andaccess to the skin region under the retainer body 210 for inspection andcleaning of the skin 30 around the skin penetration point 32.

The anchor device 200 also includes a sloped nose region 230. The slopednose region 230 can be a generally planar surface near the distal end ofthe retainer body 210 that is oriented at a different angle than thegenerally planar surfaces of the first and second retainer body portions220 a-b. The sloped nose region 230 can decline from the generallyplanar surfaces of the first and second retainer body portions 220 a-bsuch that the nose region 230 slopes downward in a distal directiontowards longitudinal shafts 242 a-b of the anchors 240 a-b (e.g., andthus downward to the skin penetration point 32 when the anchor tines 245a-b are deployed). As will be described further in reference to FIG. 14,the sloped nose region 230 can facilitate an orientation of the distalportion 48 of the catheter 202 that is directed toward the skinpenetration point 32. In this manner, the stresses that can potentiallybe exerted on the skin 30 proximal to the skin penetration point 32 bythe distal portion 48 of the catheter 202 can be reduced.

As shown in FIG. 10C, the flexible web portion 250 of the anchor device200 can be positioned, for example, generally centrally between thefirst and second retainer body portions 220 a-b. As previouslydescribed, the flexible web portion 250 can extend longitudinally from adistal face of the retainer body 210 to a proximal face of the retainerbody 210, and can be used to define the fold axis 260 about which thefirst and second retainer body portions 220 a-b are pivotable from thenon-folded condition (FIG. 10A) to the folded condition (FIG. 11A). Theleft and right retainer body portions 220 a-b can be connected toopposing sides of the flexible web portion 250. The flexible web portion250 can comprise an elastically flexible biocompatible polymer material,as discussed with reference to FIG. 2C. The flexible web portion 250 canbe biased to resiliently maintain the non-folded shape of the anchordevice 200 as depicted in FIGS. 10A-10C. When the anchor device 200 isfolded along the fold axis 260 due to a user's grasp (refer, for exampleto FIG. 4), the flexible web portion 250 can undergo elastic deformationsuch that flexible web portion 250 biases the anchor device 200 toreturn the non-folded condition (FIGS. 2A and 5) upon release from theuser. In some embodiments, the adhesive fabric strips 270 a-b comprise asingle fabric that is joined across the fold axis 260. The single fabricmay stretch and bias the anchor device 200 to the non-folded condition.

Referring now to FIGS. 11A-11B, in this example embodiment, the anchordevice 200 may include features that allow the individual anchors 240a-b to be moved relative to each other so as to facilitate bothinsertion and removal of the anchor device 200 through the skinpenetration point 32, for example, as discussed with reference to FIGS.3A-3B in regard to anchor device 100 and individual anchors 140 a-b.

Referring now to FIGS. 12-13, in some embodiments, the catheter 202 caninclude a catheter to be inserted through the penetration point 32 ofthe skin 30 as part of a medical procedure. After placement of thecatheter 202 through the penetration point 32 of the skin 30, the usercan grasp the anchor device 200 in the folded condition and approach thepenetration point 32 such that the free ends of the tines 245 a-b arecontemporaneously inserted through the penetration point 32 while thetines 245 a-b are in a generally side-by-side condition (as depicted inFIG. 12). In particular embodiments, the subcutaneous tines 245 a-b areinserted through the skin penetration point 32 while the userconveniently grasps the tabs 222 a-b of the retainer body 210 of theanchor device 200 and applies an insertion force until the convexlycurved body portions of the subcutaneous tines 245 a-b are positionedbelow the surface of the skin 30 (while the remainder of the anchordevice 200 resides external to the skin 30).

As the anchor device 200 is inserted through the penetration point 32,the tines 245 a-b are maintained in a generally non-stressedconfiguration (e.g., a first shape or a steady-state shape) whilepassing through the penetration point 32 in a manner that reduces thelikelihood of trauma to the surrounding skin tissue 30. As the tines 245a-b are collectively advanced through the penetration point 32, the freeends of the tines 245 a-b are moved beneath the dermal skin layers 36 ofthe skin 30.

When the tines 245 a-b reach the subcutaneous region 34, the retainerbody 210 can adjusted to the unfolded condition so that the tines 245a-b are shifted relative to one another, resulting in the tines 245 a-bextending outwardly away from one another (as depicted in FIG. 13).During that process of unfolding the retainer body 210, each tine 245a-b may retain their generally non-stressed configuration (e.g., thefirst shape or the steady-state shape). Thus, the anchor device 200 canbe installed in accordance with a technique that reduces or eliminatesthe need to shift the subcutaneous anchors tines 245 a-b to or from aflexed or stressed configuration during the passage through the skinpenetration point 32. As such, the subcutaneous anchors tines 245 a-bneed not undergo substantial flexing during installation or removal, andin some embodiments, the subcutaneous anchors tines 245 a-b can comprisea generally less costly material (such as stainless steel orbiocompatible polymers) rather than more costly materials required forsuperelastic flexing.

As previously described, the anchor device 200 can secure the catheter202 relative to a skin penetration point 32. With the anchor device 200positioned such that subcutaneous anchors tines 245 a-b are in theirdeployed configuration, as shown in FIG. 13, the user may remove thereleasable liners 274 a-b of the adhesive fabric strips 270 a-b,exposing the adhesive layers 274 a-b. (Alternatively, the user mayremove the releasable liners 274 a-b before installation of thesubcutaneous tines 245 a-b into the subcutaneous region 34.) After thereleasable liners 274 a-b have been removed, the previously insertedcatheter 202 can be placed in contact with the anchor device 200. Asshown in FIG. 13, the directional arrow 298 depicts an example motion ofmanually positioning the catheter 202 in contact with the anchor device200 to prepare for the coupling of the catheter 202 to the anchor device200.

Referring now to FIG. 14, the hub 42 of the catheter 202 can be placedin contact with the anchor device 200 so that the wings 24 a-b of thehub 42 are, for example, generally aligned with the correspondingadhesive fabric strips 270 a-b. In doing so, the wings 24 a-b are placedin contact with the adhesive layer 272 of corresponding adhesive fabricstrip 270 a-b, thereby temporarily retaining the catheter 202 is aposition to receive the remaining portions of the adhesive fabric strips270 a-b over an upper side of the wings 24 a-b. In order to adhesivelycouple the catheter 202 to the anchor device 202, the user may fold theadhesive fabric strips 270 a-b (with the adhesive layer 272 exposed)along the fold axes 284 a-b and onto the wings 24 a-b, preferablyaligning the tear strips 280 a-b along the side surfaces 27 a-b.

Referring now to FIG. 15, the medical device anchor system 204 of FIGS.12-13 is adhesively coupled to the medical instrument 202. For example,the adhesive fabric strips 270 a-b can be folded along the fold axes 284a-b and onto the top surfaces 29 a-b. In the embodiment shown in FIG.15, the first adhesive fabric portion 270 c is in contact with the topsurface 29 a and the first adhesive fabric portion 270 e is in contactwith the top surface 29 b. The second adhesive fabric portion 270 d maybe in contact with the bottom surface 31 a and the second adhesivefabric portion 270 e may be in contact with the bottom surface 31 b.With the adhesive fabric strips 270 a-b folded onto the wings 24 a-b andadhesively bonded to the top surfaces 29 a-b of the wings 24 a-b, thecatheter 202 is fixed to the anchor device 200.

As shown in FIG. 15, the anchor device 200 adhesively retains themedical instrument 202 (e.g., catheter) in an operative positionrelative to a portion of skin 30 (e.g., the skin penetration point 32).The medical instrument 202 is adhesively coupled to the anchor device200, as described above. The anchor device 200, in turn, is coupled tothe portion of skin 30, as described above. In such embodiments, theanchor device 200 can be secured to the patient without necessarilyrequiring sutures or adhesive tapes bonded to the skin 30. A distalportion 48 of the catheter 202 penetrates a skin penetration point 32and distally extends into the subcutaneous layer 34. In this view, itcan be seen that some embodiments of the system 204 can enable thedistal end of the hub 42 to be positioned closely to the skinpenetration point 32. Such a configuration provides a compact anchorsystem 204 that is convenient to install and maintain. Thisconfiguration can minimize the lengths of the tubing proximal to thepatient, and reduce the need for securement of such tubing or otherportions of the medical instrument 202 to the patient using tapes,adhesive dressings, and the like.

It can also be seen in FIG. 15 that the hub 42 of the catheter 202 mayoptionally inclined at an angle in relation to the skin surface 30. Suchan orientation between the hub 42 and the skin 30 may, in somecircumstances, reduce the stresses applied to the skin penetration point32 of the patient by the distal portion 48 of the catheter 202. Inparticular, the example orientation depicted in FIG. 15 enables thedistal portion 48 to be inclined at an angle in relation to the skinsurface 30 which can thereby reduce the need for the distal portion 48of the catheter 202 to have a significant bend at the skin penetrationpoint.

FIG. 16 illustrates an example of removing of the catheter 202 from theanchor device 200. In this example, the user has grasped the protrudingportions 282 a of the tear strips 280 a, and pulled the protrudingportion 282 a away from the retainer body 210, ripping the adhesivefabrics 270 a at the location of the tear strip 180 a and permittingremoval of the medical device 202 due to separation in the adhesivefabrics 270 a. FIG. 16 shows the system 204 during removal of the tearstrips 280 a and ripping of the adhesive fabrics 270 a, but it should beunderstood that both tear strips 280 a-b may be completely removed fromthe adhesive fabric strips 270 a-b, resulting in a complete separationof both adhesive fabric strips 270 a-b, for example, along the fold axes284 a-b. It is after the complete separation of the adhesive fabricstrips 270 a-b that the catheter 202 may be removed from contact withthe retainer body 210. In some examples, the catheter 202 is removedfrom contact with both the retainer body 210 and the subcutaneous layer34 before the subcutaneous tines 245 a-b are removed from thesubcutaneous layer 34.

In some embodiments, some components of the system 204 can be providedin a sterilized kit that pairs a particular type of catheter 202 orother medical instrument with a corresponding anchor device 200. Theparticular type of catheter 202 or other medical instrument in the kitis compatible for adhesively mating with the anchor device 200 in thekit. Each kit can include one or more anchor devices 200 and theparticular type of catheter 202 or other medical instrument enclosedwithin a flexible packaging material, which preferably includesindicators that identify the type of catheter 202 or other medicalinstrument that is provided along with instructions for deploying andremoving the anchor device 200. The kit may include a one-to-one ratiofor the quantity of anchor devices 200 to the quantity of catheters 202.In other embodiments, the kit may include multiple anchor devices 200(e.g., having differently sized or shaped tines 245 a-b) for eachcatheter 202 contained therein.

Alternatively, in some embodiments, the anchor device 200 can beprovided in individual, sterilized packets so that a user can readilyopen such a packet and access the selected anchor device prior toinsertion into the skin penetration point. Such individual packets caninclude a single anchor device enclosed within a flexible packagingmaterial, which preferably includes indicators that identify the typesof catheters or other medical instruments that are compatible foradhesively mating with the anchor device 200. As such, a user canreadily select one of the packets for use after the type of catheter ormedical instrument is selected for a particular patient.

Referring to now FIGS. 17A-B, some embodiments of the medical deviceanchor system include an anchor device 300 that adhesively retains amedical instrument (e.g., a catheter 102 as shown in FIG. 1, or thelike) in an operative position relative to a portion of skin. Similar tothe embodiments previously described in connection with FIGS. 1-8, theanchor device 300 can act as an intermediary member to cause theretention of the medical instrument in a desired position with respectto the skin 30. In this example, the anchor device 300 can generallyinclude a retainer body 310 (including first and second portions 320a-b), a flexible adhesive web 370, and one or more anchors 340 a-b. Theanchor device 300 is similar to the embodiments previously described inconnection with FIGS. 1-8, except that flexible adhesive web 370 isdisposed along an underside of the retainer body 310. For example, theretainer body 310 can include two separate portions 320 a-b that areaffixed to a designated region of the flexible adhesive web 370 (referto FIG. 17A), and the longitudinal fold region 360 is defined by a smallportion of the flexible adhesive web 370 positioned between opposingedges of the spate body portions 320 a-b. In this example, the flexibleadhesive web 370 can serve both as the longitudinal hinge portion (e.g.,that defines a longitudinal fold line for the retainer body 310) and asthe securement structure for the medical instrument. Optionally, duringmanufacture of the anchor device 300, the two individual body portions320 a-b (each having a corresponding anchor 340 a-b extending distallytherefrom) can be bonded to an exposed region of an adhesive layer ofthe underlying flexible adhesive web 370. The proximal regions 370 a-cof the flexible adhesive web 370 may be equipped with a release liner374 so as to preserve the portion of the adhesive layer 372 until theproximal regions 370 a-c are used to adhere to the catheter or othermedical instrument.

Similar to the anchors 140 a-b previously described in connection withFIGS. 1-8, the anchors 340 a-b extend distally from a distal end of theretainer body 310 for deployment through a skin penetration point andinto a subcutaneous layer, so as to releasably retain the anchor device300 with respect to the skin. As such, the anchor device 300 can includethe one or more anchors 340 a and 340 b that extend distally from theretainer body 310 so as to penetrate through the same skin penetrationpoint while the retainer body 310 and the flexible adhesive web 370remain external to the skin penetration point. Also similar to theanchors 140 a-b previously described in connection with FIGS. 1-8, theanchors 340 a-b can include longitudinal shaft portions 342 a-b thatextend distally to corresponding subcutaneous tines 345 a-b. Afterinsertion of the tines 345 a-b, the tines 345 a-b, reside in thesubcutaneous region so as to secure the position of the anchor device300—and the medical instrument retained thereto—relative to thepenetration point. When the tines 345 a-b are deployed in thesubcutaneous region, the anchor device 300 can be secured to the patientwithout the retainer body 310 penetrating through the dermal layers ofthe patient, and without necessarily requiring sutures or adhesive tapesbonded to the skin. As previously described, the anchor device 300 canbe installed into the skin penetration point in accordance with atechnique that reduces or eliminates the need to shift the subcutaneousanchors tines 345 a-b of the anchors 340 a-b to or from a flexed orstressed configuration. As such, the anchor tines 345 a-b may notnecessarily undergo substantial flexing during installation or removal.In these circumstances, the subcutaneous anchors may be both installedand removed from the skin penetration point advantageously without theneed for an external actuator handle or delivery device to deploy thesubcutaneous tines 345 a-b.

Still referring to FIGS. 17A-B, after installation of the subcutaneousanchor tines 345 a-b into the subcutaneous layer, the retainer body 310and the flexible adhesive web 370 can receive the catheter or othermedical instrument. For the flexible adhesive web 370 to receive thecatheter, a user may have removed releasable liner 374 from the flexibleadhesive web 370 to expose the adhesive layer 372. The catheter may beplaced in contact with the exposed flexible adhesive web 370, and a usermay fold the adhesive portions 370 a-b (e.g., along the fold axis 384)over the catheter and into engagement with the remaining portion 370 c.

Similar to the embodiments previously described in connection with FIGS.1-8, the flexible adhesive web 370 may include a tear strip 380 thatextends in a generally longitudinal direction (e.g., generally parallelto the longitudinal fold region 360 of the retainer body 310). Theflexible adhesive web 370 may be adapted such that pulling the tearstrip 380 results in the flexible adhesive web 370 separating along aninstallation of the tear strip 380 in the flexible adhesive web 370. Thetear strip 380 may be manufactured with sufficient tensile strength toremain intact as the user pulls the tear strip 380 away from theflexible adhesive web 370, and as the flexible adhesive web 370 isripped into two portions through force applied to the flexible adhesiveweb 370 by the tear strip 380. In some embodiments, the tear strip 380may include a protruding portion 382 that is adapted to be grasped bythe user with an instrument or between the user's fingers. Thus, afteradhesive coupling of the catheter to the anchor device 300, the cathetermay be removed in a straightforward manner from contact with the anchordevice 300 and subcutaneous region before the tines 345 a-b are removedfrom the subcutaneous region.

The flexible substrate 375 of the flexible adhesive web 370 can bemanufactured from a flexible material such as a textile mesh, a polymermesh, a polymer sheet, a flat web of polymer foam material, or ametallic foil. Preferably, the flexible substrate 375 is selected withthe material and thickness sufficient to bias the retainer body 310 tothe deployed configuration (as shown in FIG. 17A) after beingtemporarily adjusted to a folded condition (e.g., fold about thelongitudinal fold region 360). The adhesive layer 372 may comprise anadhesive, for example, a suitable medical adhesive. In some examples, amedical adhesive that is robust to cleaning agents and that provides apermanent hold may be employed as the adhesive layer 372. The releasableliner 374 may be formed of a polymer sheet or a wax paper, for example.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the scope of the invention. Accordingly,other embodiments are within the scope of the following claims.

1. A method of using a medical anchor system, the method comprising:advancing an anchor device toward a skin penetration point while theanchor device is in a folded condition so that a plurality ofsubcutaneous tines of the anchor device are generally adjacent to eachother and oriented to extend in substantially the same direction;inserting the subcutaneous tines through the skin penetration point andinto a subcutaneous region adjacent to an underside of a skin layerwhile the anchor device is in the folded condition, wherein each of thesubcutaneous tines has a shape which terminates at a tip of a free endduring insertion through the skin penetration point; adjusting theanchor device to a non-folded condition after the subcutaneous tines areinserted into the subcutaneous layer so that the subcutaneous tines arein an anchored position in which the free ends of the subcutaneous tinesextend generally away from one another; and adhesively securing amedical instrument to the anchor device after the subcutaneous tines areadjusted to the anchored position in the subcutaneous region, whereinthe adhesively securing comprises coupling one or more flexible adhesivemembers of the anchor device with one or more exterior surfaces of themedical instrument.
 2. The method of claim 1, wherein adjusting theanchor device to a non-folded condition comprises adjusting the anchordevice along a longitudinal folding region positioned generallycentrally between a first body portion of the anchor device and a secondbody portion of the anchor device.
 3. The method of claim 2, wherein alongitudinal fold axis is defined along the longitudinal folding region,the first body portion movable relative to the second body portion aboutthe longitudinal fold axis to adjust the anchor device to the non-foldedcondition.
 4. The method of claim 2, wherein the longitudinal foldingregion comprises a flexible web portion.
 5. The method of claim 3,wherein the one or more flexible adhesive members comprises a flexibleadhesive strip.
 6. The method of claim 5, wherein coupling the one ormore flexible adhesive members of the anchor device with one or moreexterior surfaces of the medical instrument comprises folding theflexible adhesive strip about an adhesive strip fold axis that issubstantially parallel to and offset from the longitudinal fold axis ofthe flexible web portion.
 7. The method of claim 5, wherein the flexibleadhesive strip has a lateral width extending generally perpendicular tothe longitudinal fold axis and a longitudinal length extending generallyparallel to the longitudinal fold axis, wherein the lateral width of theflexible adhesive strip is substantially greater than the longitudinallength of the flexible adhesive strip.
 8. The method of claim 5, whereinthe flexible adhesive strip extends proximally away from proximal endsof the first and second body portions and extend away from the first andsecond subcutaneous tines.
 9. The method of claim 5, comprising foldingthe first adhesive strip upon itself about the adhesive strip fold axis.10. The method of claim 5, further comprising tearing the flexibleadhesive strip along a tear strip that extends generally parallel to thelongitudinal fold axis.
 11. The method of claim 5, wherein the flexibleadhesive strip comprises a flexible substrate carrying an adhesive layeralong a major surface thereof and a releasable liner over the adhesivelayer.
 12. The method of claim 11, wherein the flexible substratecomprises at least one of a fabric mesh material, a polymer meshmaterial, and a polymer sheet material.
 13. The method of claim 1,wherein the medical instrument comprises a catheter, and wherein theflexible adhesive strip comprises an adhesive layer configured to bondwith the one or more exterior surfaces of the medical instrument.
 14. Amethod of using a medical anchor system, the method comprising:advancing an anchor device toward a skin penetration point while theanchor device is in a folded condition so that a plurality ofsubcutaneous tines of the anchor device are generally adjacent to eachother and oriented to extend in substantially the same direction, theanchor device comprising a retainer body having a first body portionthat is coupled to a second body portion about a longitudinal foldregion having a longitudinal fold axis; inserting the subcutaneous tinesthrough the skin penetration point and into a subcutaneous regionadjacent to an underside of a skin layer while the anchor device is inthe folded condition, wherein each of the subcutaneous tines has a shapewhich terminates at a tip of a free end during insertion through theskin penetration point; adjusting the anchor device along thelongitudinal fold axis of the longitudinal fold region to a non-foldedcondition after the subcutaneous tines are inserted into thesubcutaneous layer so that the subcutaneous tines are in an anchoredposition in which the free ends of the subcutaneous tines extendgenerally away from one another; and adhesively securing a medicalinstrument to the anchor device after the subcutaneous tines areadjusted to the anchored position in the subcutaneous region by couplinga flexible adhesive strip of the anchor device with one or more exteriorsurfaces of the medical instrument.
 15. The method of claim 14, whereincoupling the flexible adhesive strip of the anchor device with one ormore exterior surfaces of the medical instrument comprises folding theflexible adhesive strip about an adhesive strip fold axis that issubstantially parallel to and offset from the longitudinal fold axis ofthe longitudinal fold region.
 16. The method of claim 15, wherein theflexible adhesive strip has a lateral width extending generallyperpendicular to the longitudinal fold axis and a longitudinal lengthextending generally parallel to the longitudinal fold axis, wherein thelateral width of the flexible adhesive strip is substantially greaterthan the longitudinal length of the flexible adhesive strip.
 17. Themethod of claim 16, wherein the anchor device comprises first and secondanchors that extend distally from a distal end of the retainer body, thefirst and second anchors each comprising one of the plurality ofsubcutaneous tines.
 18. The method of claim 17, wherein the flexibleadhesive strip extends proximally away from a proximal end of theretainer body and extends away from the first and second anchors. 19.The method of claim 15, further comprising tearing the flexible adhesivestrip along a tear strip that extends generally parallel to thelongitudinal fold axis of the retainer body.
 20. The method of claim 19,wherein the flexible adhesive strip comprises a flexible substratecarrying an adhesive layer along a major surface thereof and areleasable liner over the adhesive layer.